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Clinical Trials

Research scientists and physicians are constantly trying to learn more about disease conditions. They try to understand the causes, how to prevent or delay development, or how to treat symptoms. When this research leads to a new treatment that could benefit patients, researchers first conduct tests in the laboratory. This research helps focus in on methods most likely to help patients and offers valuable information about how to use these methods safely and effectively. However, laboratory research cannot predict all of the benefits, risks or effects that may emerge in actual patients.

A cancer treatment clinical trial is a study conducted with patients in order to evaluate a new therapy, diagnostic test or prevention method. Each study is designed to answer scientific questions that enable the medical community to find better ways to help patients. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

The standard treatments being used in hospitals today are the result of clinical trials done in the past. They are also often used as building blocks for new and better treatments in the future. Some new treatments are designed based on what has worked in the past while others are based on new advances in science and technology.

Participation in cancer treatment clinical trials is always voluntary. If you are interested in a clinical trial or asked to participate in one, learn as much as you can before you make up your mind. Only patients who want to participate will take part and all participants can change their minds at any time without losing any benefits. Always remember that you are in control of your medical treatment.

Advantages of Participating In a Trial

Cancer Treatment Clinical Trials

Medical science continues to advance the frontiers of understanding and develop new and effective treatments for many medical conditions. In many cases, life-saving treatments that define the current standard of care today were unheard of a decade ago. Similarly, work taking place right now in research laboratories will make some of our current treatments obsolete, offering hope to patients who currently have few effective options.

Cancer treatment clinical trials give patients the opportunity to play a role in developing promising new therapies and in ensuring that these therapies become available to all patients in need. Without the benefit of the valuable information gained through clinical trials, medical research could not move forward as it does.

Participating in a clinical trial can aid you directly by giving you access to potentially helpful treatments before they are available to the general public. Your participation may mean that you are among the first to benefit from the latest cutting-edge research as it moves out of the laboratory and into doctors' hands.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

The clinical trial process depends on the kind of trial being conducted (See Different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

The benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

Play an active role in their health care.

Gain access to new research treatments before they are widely available.

Obtain expert medical care at leading health care facilities during the trial.

Help others by contributing to medical research.

Risks

There are risks to clinical trials.

There may be unpleasant, serious or even life-threatening side effects to experimental treatment.

The experimental treatment may not be effective for the participant.

The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Different types of cancer treatment clinical trials?

Treatment. These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, and vaccines or other treatments that stimulate a person’s immune system to fight cancer. Combinations of different treatment types may also be tested in these trials.

Prevention. These trials test new interventions that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past; these trials test interventions that may help prevent the return (recurrence) of the original cancer or reduce the chance of developing a new type of cancer

Screening. These trials test new ways of finding cancer early. When cancer is found early, it may be easier to treat and there may be a better chance of long-term survival. Cancer screening trials usually involve people who do not have any signs or symptoms of cancer. However, participation in these trials is often limited to people who have a higher than average risk of developing a certain type of cancer because they have a family history of that type of cancer or they have a history of exposure to cancer-causing substances (e.g., cigarette smoke).

Diagnostic. These trials study new tests or procedures that may help identify, or diagnose, cancer more accurately. Diagnostic trials usually involve people who have some signs or symptoms of cancer.

Quality of lifeor supportive care. These trials focus on the comfort and quality of life of cancer patients and cancer survivors. New ways to decrease the number or severity of side effects of cancer or its treatment are often studied in these trials. How a specific type of cancer or its treatment affects a person’s everyday life may also be studied.

Clinical Trial Phases

Cancer Treatment Clinical Trial Phases

The testing of new treatments in clinical trials is divided into four phases:

Phase I trials help researchers determine the most appropriate dosage and to identify any side effects that may be associated with the new treatment. This phase also helps determine the best way to deliver the new treatment – for example if a drug should be given by injection or by mouth. Phase I trials typically involve fewer than 100 participants.

Phase II trials test the treatment in patients who have the targeted medical condition in order to begin determining its effectiveness. Researchers continue to track the drug's safety and side effects. Phase II trials involve more patients, but are still very limited in size.

Phase III trials compare the new treatment to one or more standard therapies currently in use among patients. The new treatment is sometimes combined with established therapies to determine if the combination is more effective than standard therapy alone. Safety and side effects continue to be tracked as the study expands to include hundreds or even thousands of patients.

Phase IV trials can begin once the treatment is approved for general use to continue to monitor its safety and effectiveness and to give researchers and physicians additional information about how best to employ the new treatment.

The Role of the FDA

The Role of the FDA

The Food and Drug Administration (FDA) is the federal agency responsible for making sure that new drugs and medical devices are safe and effective. No treatment is risk-free, but it is the FDA's role to judge whether a new treatment's benefits to the patient outweigh its risks. They oversee every phase of a clinical trial and decide if the evidence supports continued testing and, eventually, approval for doctors to prescribe the new treatment in this country.

Informed Consent

Informed Consent

The informed consent process provides patients the information they need in order to make an educated decision to begin or continue to participate in a clinical trial. The research team will discuss with you the trial's purpose, procedures, risks and potential benefits, and your rights as a participant. The team will also provide a document that includes all this information for your reference throughout the study and will continue to provide information to you during your participation in the trial. Your signature on the informed consent document gives your official consent to participate in the study, but you always retain the right to leave the study at any time for any reason.

Who Sponsors Clinical Trials

Who Sponsors Clinical Trials?

The sponsor can be the pharmaceutical company, research institution, or health organization that funds a clinical trial. This funding source can be a commercial enterprise, a governmental agency, or a philanthropic organization.

Cost of Participation

Cost of Participation

The research costs associated with a clinical trial, including data collection and analysis, health care professionals who work on the research project, and tests performed for research purposes are paid by the research sponsor.

Other costs for medical goods and services, including doctors' professional fees, hospital stays, laboratory tests, and medical imaging made necessary by your medical condition independent of your participation in the clinical trial, are often not covered by the research sponsor. Third-party health insurance may pay for some or all of these costs, but their obligation to do so varies among insurance plans. Be aware that health care delivered in the context of a clinical trial will most often be considered "investigational." Investigational therapies are often excluded from coverage under medical plans. You should discuss the financial aspects of your participation in a clinical trial with both your physician and with a representative of your insurance plan.

Questions to Ask Your Doctor

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

What is the purpose of the study? How long will I be in the study? How many people will participate in the study? In which phase of the study will I participate? How often will I need to go to the hospital or clinic? What tests will I need? Will my medical records remain confidential? Is there a chance that I will receive a placebo in the study? Will I continue to see my own personal doctor? Will there be any cost to me? Will participating in the study affect my daily life? What kind of long-term follow-up care is included in the study? Will I learn the results of the study? If so, when? What are the potential benefits and possible risks?

Biomarker Registry Trial: A Registry of Caris Target Now Test Results (Biomarker Expression Patterns) and Hematopoietic Diagnostics for Evaluation of Correlation with Clinical Outcomes for Cancer and Other Patients

Trial Evaluating Lapatinib or Trastuzumab: A Randomized, open-label, phase III study of Taxane based chemotherapy with Lapatinib or Trastuzumab as first Line therapy for women with HER2/neu positive metastatic breast cancer

Trial Evaluating T-DM1: A Randomized, 3 arm, Multicentre, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined with Pertuzumab or T-DM1 Combined with Pertuzumab-Placebo (blinded for pertuzumab), Versus the Combination of Trastuzumab plus Taxane, as First Line Treatment in HER2- Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer (MBC)

Trial Evaluating KW-2450: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination with Lapatinib and Letrozole in Subjects with Advanced or Metastatic Breast Cancer whose Tumors Overexpress HER2

*Trial Evaluating Neratinib vs Lapatinib: A study of Neratinib plus Capecitabine versus Lapatinib Plus Capecitabine in patients with HER2+ with HER2+ metastatic Breast Cancer who have received two or more prior HER2-Directed regimens in the metastatic setting (NALA)

*Trial Evaluating Enzaluamide with Trastuzumab: A Phase 2, Multicenter, open-label study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

Trial Evaluating Capecitabine with Bevacizumab: A Randomized Phase 2 Study of 7 on/7 off Capecitabine in Combination with Bevacizumab and either Short-course Irinotecan or Short-course Oxaliplatin as First-Line Treatment for Patients with Metastatic Colorectal Cancer

Trial Evaluating Epi proColon: Comparison of the Performance of the Epi proColon and Fecal Immunochemical Test Post Colonoscopy in Subjects with Colorectal Cancer and Pre Colonoscopy in Subjects from Guideline- Eligible Screening Population

Trial Evaluating Bevacizumab with Capecitabine: A Double-Blind, Randomized, Multicenter, Phase III Study of Bevacizumab in Combination with Capecitabine and Cisplatin versus Placebo in Combination with Capecitabine and Cisplatin, as First-Line Therapy in Patients with Advanced Gastric Cancer

An Observational Trial for Patients with GIST: An Observational Database to Obtain Data on Variations in Current Diagnostic and Therapeutic Management of Patients with GIST in a Variety of Practice Setting

*Trial Evaluating Trastuzumab: A Randomized, Open-label, Multicenter Phase IIIb Study Comparing Two Trastuzumab Dosing Regimens, Each in Combination with Cisplatin/Capecitabine Chemotherapy, as First-line Therapy in Patients with HER2-positive Metastatic Gastric or Gastro-esophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment For Metastatic Disease

Head and Neck:

Trial Evaluating Cetuximab: A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone versus Boehringer Ingelheim Manufacturing Processes, in Combination with Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients with Locoregionally Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Hematology:

*Trial Evaluating Momelotinib: A Phase 2, Open-label, Randomized Study to Evaluate the Safety and Efficacy of Momelotinib in Subjects with Polycythemia Vera or Essential Thrombocythemia

*Trial Evaluating Brentuximab Vedotin: A Phase 1/2 Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination with Bendamustine in patients with Relapsed or Refractory Hodgkin Lymphoma(HL)

ITP:

Trial Evaluating IGIV3I: A Multi-Center, Prospective, Open-Label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients with Idiopathic (Immune) Thrombocytopenic Purpura

Leukemia/Lymphoma:

Trial Evaluating Lintuzumab: A Phase IIB, Randomized, Double Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older with Previously Untreated AML

Trial Evaluating Farletuzumab: A Randomized, Double-Blind, Placebo-controlled, Study of the Safety and Efficacy of Farletuzumab in combination with Carboplatin and Paclitaxel or Docetaxel Followed by Pemetrexed in Chemotherapy-naïve Subjects with Stage IV Adenocarcinoma of the Lung with Wild Type EGFR

Phase III Study Evaluating Netapitant: A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination with Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receivingmoderately Emetogenic Chemotherapy

Trial Evaluating TXA127: Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube or Peritoneal Carcinoma

Trial Evaluating Denosumab: A Randomized, Double - Blind Multicenter Study of Denosumab Compared with Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Men with Hormone Refractory Prostate Cancer

Observational Study of Docetaxel: Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes In Patients with Metastatic Castrate-Resistant Prostate Cancer (CRPC) With Progression During Or After A First - Line Docetaxel - Based Regimen